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RecruitingNot ApplicableNCT07293975

Pain Control During Braces Removal Using Transcutaneous Electrical Nerve Stimulation and High-Frequency Vibration

Assessment of Transcutaneous Electrical Nerve Stimulation and High-Frequency Vibration for Pain Control During Bracket Debonding: A Clinical Trial Study

Sponsor

University of Baghdad

Enrollment

90 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Summary

This study aims to find the best method to reduce pain during braces removal. We are comparing transcutaneous electrical nerve stimulation (TENS), high-frequency vibration, and a control group with no additional intervention. People who have completed orthodontic treatment and need their braces removed can take part. Participants will be randomly assigned to one of the three groups. The vibration device will be applied during the braces removal, while TENS will be applied just before the procedure. Before the procedure, participants' anxiety will be measured using the Modified Dental Anxiety Scale (MDAS). During and after the procedure, pain will be assessed using a Visual Analog Scale (VAS) from 0 to 100, and participants will rate their satisfaction using a Numerical Rating Scale (NRS) from 0 to 10. The purpose of this research is to help orthodontists identify the method that makes braces removal less uncomfortable, more tolerable, and more satisfying for patients.

Eligibility

Min Age: 15 YearsMax Age: 35 Years

Inclusion Criteria6

  • Patients scheduled for fixed orthodontic appliance removal.
  • Permanent dentition present, including both anterior and posterior teeth.
  • Age between 15-35 years.
  • Ability to provide informed consent and comply with study procedures.
  • General health adequate for routine orthodontic care.
  • No history of regular or recent medication intake within the preceding 24 hours, including painkillers, corticosteroids, or anti-flu drugs.

Exclusion Criteria6

  • Patients with craniofacial anomalies, systemic conditions affecting pain perception, or taking medications influencing nociception.
  • Teeth with extensive restorations or prostheses that prevent standard bracket debonding.
  • Patients with known allergy or contraindication to TENS or vibration devices.
  • Pregnant women.
  • Active periodontal disease, including gingival recession or tooth mobility exceeding Grade I.
  • Excessive gingival overgrowth that may impede debonding or influence study outcomes.

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Interventions

DEVICETranscutaneous Electrical Nerve Stimulation (TENS)

TENS is applied immediately before orthodontic bracket removal in a single session to reduce pain and improve patient satisfaction.

DEVICEHigh-Frequency Vibration

High-frequency vibration is applied during orthodontic bracket removal in a single session to reduce pain and improve patient satisfaction.

Locations(1)

College of Dentistry, University of Baghdad

Baghdad, Iraq

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NCT07293975